What is Octaplex (prothrombin complex concentrate)?

From the Guidelines

Octaplex is a prothrombin complex concentrate (PCC) medication used to rapidly reverse anticoagulation in patients taking vitamin K antagonists like warfarin, or to treat bleeding in patients with deficiencies of specific clotting factors. It contains four essential human blood clotting factors: II, VII, IX, and X, along with Proteins C and S which help regulate coagulation. Octaplex is administered intravenously with dosing typically calculated based on the patient's weight, current INR (International Normalized Ratio), and the target INR. For warfarin reversal in emergency situations such as life-threatening bleeding or urgent surgery, doses generally range from 25-50 IU/kg, as recommended by guidelines 1. The medication works quickly, usually reversing anticoagulation within 10-30 minutes of administration, making it significantly faster than fresh frozen plasma, as demonstrated in studies comparing PCCs to FFP 1. Potential side effects include thromboembolic events, so patients should be monitored carefully, and the risk of these events should be weighed against the benefits of rapid anticoagulation reversal 1. Octaplex should be used cautiously in patients with liver disease, recent heart attack, or history of thrombosis, as these conditions may increase risk of complications. It's essential to note that while Octaplex rapidly reverses anticoagulation, vitamin K should also be administered to maintain the reversal effect once the PCC wears off, as recommended in the guidelines for warfarin reversal 1. Some key points to consider when using Octaplex include:

• The importance of accurate dosing based on patient weight and INR level
• The need for careful monitoring for thromboembolic events
• The potential benefits of using Octaplex over FFP in emergency situations, including faster reversal of anticoagulation and reduced risk of adverse reactions
• The importance of administering vitamin K in conjunction with Octaplex to maintain the reversal effect. Overall, Octaplex is a valuable tool in the management of patients taking vitamin K antagonists who require rapid reversal of anticoagulation, and its use should be guided by the latest clinical evidence and guidelines 1.

From the Research

Definition and Composition of Octaplex

• Octaplex is a prothrombin complex concentrate (PCC) used to boost thrombin potential, support clot formation, and aid in the treatment and prophylaxis of bleeding 2.
• It is a four-factor PCC, containing coagulation factors II, VII, IX, and X, as well as anticoagulant proteins C and S, which potentially affords a balanced hemostatic effect and mitigates thrombosis risk 2.
• Octaplex is supplied as a freeze-dried powder for reconstitution and intravenous infusion, and its production involves two virus inactivation/removal steps: solvent/detergent treatment and nanofiltration 2.

Clinical Uses of Octaplex

• Octaplex is approved for acquired deficiency of vitamin K-dependent clotting factors, such as those induced by vitamin K antagonists (VKAs, e.g., warfarin), and for congenital deficiency of factors II and X 2.
• It is used for rapid reversal of anticoagulation in bleeding patients or prior to urgent surgery, and has been shown to be effective and safe in these situations 3, 4.
• Octaplex has also been used in various acquired coagulopathies, including post-cardiopulmonary bypass bleeding, trauma-induced coagulopathy, coagulopathy in liver failure, and major bleeding due to anti-FXa (anti-Xa) inhibitors 5.

Efficacy and Safety of Octaplex

• Studies have demonstrated the efficacy of Octaplex in reducing the international normalized ratio (INR) and achieving rapid reversal of anticoagulation 3, 4.
• Octaplex has been shown to be safe, with a low risk of thrombotic events and no significant increase in D-dimer levels 3, 4.
• The use of Octaplex has been supported by recent guidelines for direct oral anticoagulant-associated bleeding, cardiac surgery, and trauma/emergencies 2.

Comparison with Other Prothrombin Complex Concentrates

• Octaplex has been compared to other commercially available PCCs, and has been shown to have similar levels of coagulation factors II, VII, IX, and X, but differing levels of coagulation inhibitors and purity 6.
• The thrombin inhibitory capacity of Octaplex has been found to be lower than some other PCCs, such as Beriplex P/N 6.